Director of Analytical Development

THE COMPANY
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-
class therapies for patients with liver and cardiometabolic diseases who lack optimal
treatment options. The company is focused on rapidly advancing its lead candidate,
pegozafermin, through Phase 3 clinical development for the treatment of metabolic
dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG).
Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21
(FGF21) analog with unique glycoPEGylated technology that optimizes biological activity
through an extended half-life. The company is headquartered in San Francisco.

THE ROLE
Reporting to the Senior Director, Analytical Development, the Director of Analytical
Development will manage late phase analytical development activities as they relate to
ongoing CQA development strategy, process characterization, comparability analysis, PPQ,
and BLA. The individual must be able to manage complex and intertwined scientific, technical,
and operational CMC related activities. The position will support the Companys ongoing drug
development and manufacturing activities for commercialization at external Contract
Development and Manufacturing Organization (CDMO) and contract testing labs (CTLs). This
person will manage analytical development, Tech Transfer protocol development, review, and
approval. This individual will also contribute to regulatory submissions and support review of
development, qualification, and validation protocols and reports.

THE RESPONSIBILITIES

• Manage late phase analytical development activities to support, process characterization,
  PPQ, and BLA
• Manage multiple global CDMOs and CTLs for tech transfer and qualification of
  analytical methods to support purity/ impurity assessment, strength, potency and
  identity testing at multiple CTLs
• Ensure that test methods are in place and aligned across the vendor network to support
  in-process testing, lot release, stability, shelf-life extensions, and product safety
• Extensive knowledge and hands-on experience with late phase development activities
• Experience with analytical methods including, HPLC, peptide mapping, mass spec,
  ELISA, host cell protein analysis, host cell DNA analysis by PCR, potency, SDS-PAGE,
  icIE, SoloVPE, microbial methods, container closure methods
• Write, review, and/or approve technical documents including development reports, tech
  transfer reports, manufacturing batch records, campaign summary reports, risk
  assessment and deviation investigation reports etc.
• Partner with QA for resolution of analytical issues related to lot release, stability
  testing, deviation/OOS investigation, change control and data trending analysis
• Author and review documents for regulatory submissions as technical SME. Support
  regulatory interactions with the FDA and other regulatory authorities
• Work closely and coordinate with QC/QA to execute plans for overall compliance;
  phase appropriate qualifications and validations as required by cGMP, ICH, FDA, and
  other regulations

THE QUALIFICATIONS

• BS, M.S., PhD or equivalent in biology, biochemistry, chemical engineering, biochemical
  engineering or related field
• 12 years of industry experience in CMC operations / analytical development
• Late-stage development and commercialization experience is highly preferred
• Solid working knowledge of analytical methods is required
• Strong scientific knowledge on product characterization is required
• Experience selecting and managing US and International vendors (CMOs, CTLs, etc.) is
  required
• Experience in tech transfer and managing CDMOs on analytical method development
  and troubleshooting and OOS investigations is required
• Experience in regulatory filings (i.e. IND, CTA, BLA etc.) is plus
• Demonstrated history of simultaneously managing multiple projects; success working in a
  dynamic, fast-paced, timeline-driven environment with short lead times
• Strong people managing skills with ability to assert and influence CMOs and achieve
  goals
• Demonstrated strategic thinking to assess and improve processes to meet global
  business needs
• Superior problem-solving skills: diagnosing complex issues; developing &
  implementing solutions by collaborating with the appropriate internal and external
  stake holders
• A good team player with track record of collaborations/influence up, down and across
  teams/organization
• Excellent written and verbal communication skills including succinctly translating
  complex/technical information to/for a variety of audiences

SALARY & LEVEL
89bio considers a range of factors when determining the salary and level. These
considerations mean actual salary and level may vary. The salary range for this position is
$196,000 to $236,000 and will be commensurate with experience.

THE PERKS

• Competitive health insurance coverage
• Generous PTO allowance
• 401k match
• Employee Stock Purchase Plan (ESPP)
• Commuter Benefits
• Women's forum / mentoring
• Office based in the heart of San Francisco, near plenty of shops and restaurants
• Fun opportunities to engage with co-workers in-person and remotely
  

All qualified applicants will receive consideration for employment without regard to race, sex,
color, religion, sexual orientation, gender identity, national origin, protected veteran status,
or based on disability.
Notice to Recruiters: To protect the interest of all parties, 89bio does not accept unsolicited
resumes and we ask that employees, hiring managers and executives not be contacted
directly. All recruitment is managed through the 89bio Talent Acquisition Team.